MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 5F; CHRONIC CATHETER

Catalog Number	0720515
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a chronic catheter placement procedure in the left chest, it was allegedly noticed that there was a bent in the tunneled catheter.It was further reported that guidewire was advanced to straighten the catheter curve.Reportedly the guidewire was allegedly difficult to remove from lumen.The procedure was completed with another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: section a through f: the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one powerline 5f d/l catheter with a loaded straight tip guidewire was received for evaluation.The straight tip was loaded within the red luer.The straight tip guidewire was noted exposed at the distal end of the catheter.An attempt to remove the loaded guidewire from the red luer of the catheter was performed and was successful.Resistance was felt throughout.The guidewire was noted to be bent on the center portion.Therefore, the investigation is confirmed for the reported deformation and identified physical resistance issues.However, the investigation is inconclusive for the reported difficult to remove as as the exact circumstance at the time of the reported event was unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during a chronic catheter placement procedure in the left chest, it was allegedly noticed that there was a bent in the tunneled catheter.It was further reported that guidewire was advanced to straighten the catheter curve.Reportedly the guidewire was allegedly difficult to remove from lumen.The procedure was completed with another device.There was no reported patient injury.

• Brand Name: POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 5F
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21134617
• Report Number: 3006260740-2024-08313
• Device Sequence Number: 20728716
• Product Code: LJS
• UDI-Device Identifier: 00801741036613
• UDI-Public: (01)00801741036613(11)240618(17)280731(10)REJS0025
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0720515
• Device Lot Number: REJS0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown